News Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS by Patricia Silva, PhD | December 13, 2016 Share this article: Share article via email Copy article link Health CanadaĀ has approved Zinbryta (daclizumab)Ā as aĀ treatment for adults with active relapsing-remittingĀ multiple sclerosis (RRMS), BiogenĀ and AbbVieĀ announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTAā¢ is the first once-monthly, self-administered treatment for MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed ZINBRYTAā¢ significantly reduced relapses and brain lesions for up to three years compared to AVONEXĀ®Ā (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring,” Lisa Hickey, vice president and managing director at Biogen Canada, said in a news release. Zinbrytaās approval by Health Canada was based on data fromĀ the global Phase 3 DECIDE (NCT01064401) and Phase 2b SELECT (NCT00390221)Ā clinical trials, in which Zinbryta 150 mg, administered once per month, improved the clinical outcomes of MS disease activity in 2,400 patients with relapsingĀ MS, in comparison toĀ AvonexĀ (30 mcg administered every week) and aĀ placebo. Specifically, in both clinical trials, Zinbryta significantly reduced by 45 percent the annualized relapse rate (ARR) compared to AvonexĀ at up to 144 weeks, and by 54 percent compared to placebo at 52 weeks. In the DECIDE trial, Zinbryta also demonstrated superior efficacy to Avonex across variousĀ measures of MS disease activity (as seen in relapses and by MRI), including a 54 percent reductionĀ in the mean number of new or newly enlarging lesions (T2-hyperintense lesions)Ā at 96 weeks. Zinbryta is associatedĀ withĀ serious safety risks, including liver injury and the possibility of autoimmune hepatitis, and with immune disordersĀ like non-infectious colitis, skin reactions, and enlarged lymph nodes (lymphadenopathy). Because of theseĀ risks, the drug’s Product Monograph includes a Serious Warnings and Precautions boxĀ regardingĀ possible side effects. Access to the drugĀ inĀ Canada will be available through a Biogen controlled distribution program, called Biogen ONEĀ Support Program, and patients wishing to use the treatment must be registered in that program, the company said in its release. “MS affects each person differently, so having additional therapeutic options to address their needs throughout the course of this long term disease is very important news,” Marcelo Kremenchutzky, MD, Chapman Chair in MSĀ Clinical ResearchĀ at London Health Sciences Centre, and an associate professor in Neurology atĀ Western UniversityĀ inĀ Ontario, said. “Daclizumab beta provides a meaningful new option for theĀ treatment of people with MS,Ā withĀ demonstrated efficacy and convenientĀ once-monthly dosing.” Zinbryta is a humanized monoclonal antibody that binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. TheseĀ immune cells are overly expressed in MS, and Zinbryta is thought toĀ deplete the activated T-cells andĀ increase other cells that regulate the immune response (namely NK cells).Ā The U.S. Drug and Food Administration (FDA) approved Zinbryta, under a similar indication,Ā in May 2016. “ZINBRYTAā¢ hasĀ a different target in the immune system compared to other MS therapies,” Kremenchutzky said. “ZINBRYTAā¢ provides both patients and clinicians an additional and distinctĀ treatment optionĀ to consider. Having options is critical whenĀ the course of MS can be so different from patient to patient.” Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags AbbVie, AVONEX, clinical trials, disease activity, Health Canada, ZINBRYTA
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